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Safety Study of Cenderitide in Stable Chronic Heart Failure

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cenderitide

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Chronic Heart Failure, Natriuretic Peptides, Cenderitide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Male or female, ≥ 18 years of age
Body Mass Index (BMI) of 18-40 kg/m2, inclusive
Current or historical New York Heart Association (NYHA) functional class ≥ II
At least one of the following: documented systolic heart failure with an ejection fraction (EF) ≤ 40% and/or a historical measurement of plasma BNP ≥ 150 pg/mL (or NT-proBNP ≥ 600 pg/mL)
Systolic blood pressure 100-160 mmHg
Stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to Screening

Key Exclusion Criteria:

Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
Current clinical diagnosis of acute decompensated heart failure (ADHF)
Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to Screening.
Symptomatic postural hypotension
Evidence of uncorrected volume or sodium ≤ 130 mmol/L or other condition that would predispose the patient to adverse events
Clinically significant aortic or mitral valve stenosis
Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
Severe renal failure defined as creatinine clearance < 45 mL/min as estimated by either the Cockcroft-Gault or the MDRD equations
Significant pulmonary disease (e.g., history of oral daily steroid dependency, history of Carbon Dioxide (CO2) retention or need for intubation for acute exacerbation, or currently receiving IV steroids)
Known hepatic impairment as indicated by any of the following: A) total bilirubin > 3 mg/dL; B) albumin < 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction; C) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction

Sites / Locations

Orange County Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cenderitide

Arm Description

Cenderitide will be administered as four, 48-hour, continuous, subcutaneous infusion rates of 0.5, 1.0, 2.0 and 3.0 ng/kg/min totaling up to eight sequential days of dosing.

Outcomes

Primary Outcome Measures

Safety and tolerability as assessed by changes in vital signs (blood pressure, heart rate, and body temperature), clinical laboratory tests, adverse events, 12-lead ECGs, and physical examinations compared to pre-dose, baseline measurements.

Pharmacokinetic (PK) profile of cenderitide as measured in area under the blood concentration-curve (AUC) from time zero to 48 hours post each infusion rate start, maximum blood concentration (Cmax), and time of maximum blood concentration (Tmax).

Pharmacodynamic (PD) response as assessed by changes in blood pressure, heart rate, weight, fluid balance (intake/output), plasma cGMP, ANP, NT-proBNP, and aldosterone, and urine cGMP compared to pre-dose baseline assessments.

Secondary Outcome Measures

Full Information

NCT ID

NCT02359227

First Posted

February 2, 2015

Last Updated

February 6, 2020

Sponsor

Capricor Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02359227

Brief Title

Safety Study of Cenderitide in Stable Chronic Heart Failure

Official Title

A Study Assessing the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Open-Label, Continuous, Stepwise, Dose Increasing, Subcutaneous Infusion of Cenderitide Via the Insulet Drug Delivery System in Subjects With Stable, Chronic Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

April 2, 2015 (Actual)

Study Completion Date

April 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Capricor Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Planned enrollment is approximately twelve subjects with stable chronic heart failure. Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug Delivery System. Planned infusion rates of cenderitide will be administered to subjects continuously during four, 48-hour infusion periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Chronic Heart Failure, Natriuretic Peptides, Cenderitide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cenderitide

Arm Type

Experimental

Arm Description

Cenderitide will be administered as four, 48-hour, continuous, subcutaneous infusion rates of 0.5, 1.0, 2.0 and 3.0 ng/kg/min totaling up to eight sequential days of dosing.

Intervention Type

Drug

Intervention Name(s)

Cenderitide

Intervention Description

Cenderitide is a dual receptor natriuretic peptide.

Primary Outcome Measure Information:

Title

Time Frame

Measurements performed at regular intervals on Days 1-10, and at the safety follow-up visit (Day 16 ± 2 days).

Title

Time Frame

PK blood collection at regular intervals on Days 1-10.

Title

Time Frame

PD assessments performed at regular intervals on Days 1-10, and at the safety follow-up visit (Day 16 ± 2 days).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Male or female, ≥ 18 years of age Body Mass Index (BMI) of 18-40 kg/m2, inclusive Current or historical New York Heart Association (NYHA) functional class ≥ II At least one of the following: documented systolic heart failure with an ejection fraction (EF) ≤ 40% and/or a historical measurement of plasma BNP ≥ 150 pg/mL (or NT-proBNP ≥ 600 pg/mL) Systolic blood pressure 100-160 mmHg Stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to Screening Key Exclusion Criteria: Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds Current clinical diagnosis of acute decompensated heart failure (ADHF) Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to Screening. Symptomatic postural hypotension Evidence of uncorrected volume or sodium ≤ 130 mmol/L or other condition that would predispose the patient to adverse events Clinically significant aortic or mitral valve stenosis Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) Severe renal failure defined as creatinine clearance < 45 mL/min as estimated by either the Cockcroft-Gault or the MDRD equations Significant pulmonary disease (e.g., history of oral daily steroid dependency, history of Carbon Dioxide (CO2) retention or need for intubation for acute exacerbation, or currently receiving IV steroids) Known hepatic impairment as indicated by any of the following: A) total bilirubin > 3 mg/dL; B) albumin < 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction; C) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Neutel, MD

Organizational Affiliation

Orange County Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orange County Research Center

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

12. IPD Sharing Statement

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Safety Study of Cenderitide in Stable Chronic Heart Failure

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